Marcus Hompesch, President and CEO of the California-based Profil Institute, told BioPharma-Reporter.com that the market seems ripe to grow as he’s seeing an uptick in clinical trials around insulin biosimilars, and as some of the more established players, such as Sanofi and Lilly, are jumping in with both feet.
But the expectations for biosimilars are different from those applied to generics, Hompesch told us, noting that their manufacturing “introduces a higher level of risk because it’s never a copy and paste for a biologic…It may eventually translate into significant clinical differences.”
But he added that he does not anticipate “any significant surprises if the quality of manufacturing is at the level of the FDA expectations.”
According to a report from Decision Resources, biosimilar insulins and insulin analogues stand to erode $6.1bn in brand sales in the US and Europe over the next four years.
But whether the pricing of biosimilars will deliver the cost savings some are expecting remains to be seen.
“There has been some speculation about whether biosimilar insulins will lead to better pricing or better accessibility but no one knows the answer right now,” Hompesch said. He added that as biosimilar regulations continue to diverge worldwide -- echoing other experts -- he expects many countries will follow the lead of the EU.
Hompesch said he believes we will see “at least one approval, if not two or three, in the next 10 years,” with insulin glargine and insulin lispro as the frontrunners.
Lilly and Boehringer Ingelheim’s biosimilar version of insulin glargine may not hit the market until the middle of 2015, which is when the patent for Sanofi’s $8bn-per-year treatment, known as Lantus, expires.
Merck and Samsung Biologics also announced in February that they would team up to develop an insulin glargine, while Mylan and Biocon announced a similar collaboration for glagine and lispro. But Sanofi isn’t going to go quietly into the night as it’s also developing an improved version of Lantus, which it hopes to bring to market before its patents expire.
In other markets, non-innovator biosimilars of insulin glargine are also being marketed or registered in China, Mexico, India, Pakistan, Peru, and Thailand even though these countries do not currently have biosimilar regulatory processes in place, according to a study in Diabetes Technology and Therapeutics.
Hompesch stressed that these countries’ approvals of biosimilars could have unintended consequences, and make matters worse for countries trying to hammer out their own regulations.
And Biopharma-Reporter will be delving deeper into the issues affecting biosimilars with a free virtual event on September 26. Join four industry experts as they discuss the development, manufacture and sale of such products in a 60 minute seminar hosted by our Editor-in-Chief Gareth Macdonald. Click here for more details...